JP2024018959A - Composition for external application - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a composition for external application that contains a medicinal component and can form a coating layer with enhanced durability and moisture resistance.

SOLUTION: A composition for external application contains the following components (A)-(D): (A) a medicinal component (B), water-insoluble polymers, (C) a nonvolatile base and (D) a volatile solvent. The component (B) includes two or more selected from the group consisting of (B1) a cellulosic polymer, (B2) an acrylic polymer, and (B3) a vinyl polymer. The composition for external application has a viscosity of 1.0 mPa s or more and 10,000 mPa s or less at 25°C.

SELECTED DRAWING: None

COPYRIGHT: (C)2024,JPO&INPIT

Description

The present invention relates to an external preparation composition.

Liquid skin preparations and patches containing medicinal ingredients such as anti-inflammatory and analgesic ingredients and sterilizing and disinfecting ingredients are known. However, existing liquid external skin preparations have problems such as being easily rubbed off by clothes etc. after being applied to the skin and making it difficult to continuously release medicinal ingredients to the skin. If a patch containing a medicinal ingredient is difficult to follow the skin and easily peels off, it will be difficult to continuously release the medicinal ingredient to the skin. On the other hand, patches that are highly adhesive to the skin have the problem of increasing the burden on the skin when peeled off from the skin. Patch preparations also have problems in practical use, such as being prone to rashes and being concerned about their appearance when applied to the skin.

Therefore, film-forming preparations that can continuously release medicinal ingredients into the skin are being investigated. Film-forming preparations can form a film when applied to the skin, so they are less likely to rub off compared to liquid skin preparations. It is also preferable because it does not stand out like a patch when applied to the skin, and there is less burden on the skin when removing it from the skin.

For example, Patent Document 1 discloses that a film-forming external skin composition containing a film-forming polymer including a cellulose polymer and a vinyl polymer, a polyhydric alcohol, and a volatile solvent is used, and the film formed covers the affected area. It protects the skin and adheres firmly to the skin, while also being highly flexible, making it easy to use without causing discomfort, forming a film that is resistant to movement and abrasion and difficult to peel off, and has excellent application properties. Disclosed.
Patent Document 2 discloses a film-forming method that contains a stock solution containing a film-forming agent and an organic solvent with a predetermined boiling point, and a propellant, and contains an alkyl acrylate/vinyl acetate copolymer as the film-forming agent. It is disclosed that the aerosol composition has excellent skin protection properties and can form a film on the skin that is excellent in both removability after application and water resistance against sweat and the like.

JP 2021-6522 Publication International Publication No. 2022/059618

As mentioned above, Patent Document 1 describes the durability of the film formed, and Patent Document 2 describes the resistance of the film to sweat, etc., but the durability and moisture resistance of the film based on these conventional techniques are not practical in actual use. It was not sufficient and there was room for further improvement.
The present invention relates to an external preparation composition containing a medicinal ingredient and capable of forming a film having excellent durability and moisture resistance.

The present inventors have discovered that an external preparation composition containing a medicinal ingredient, two or more predetermined water-insoluble polymers, and a predetermined solvent component and having a predetermined viscosity can solve the above problems.
That is, the present invention relates to the following.
[1] The following components (A) to (D):
(A) a medicinal ingredient (B) a water-insoluble polymer (C) a non-volatile base (D) a volatile solvent; B2) It contains two or more selected from the group consisting of acrylic polymers and (B3) vinyl polymers, and the viscosity of the external preparation composition at 25° C. is 1.0 mPa·s or more and 10,000 mPa·s or less. , external preparation composition.
[2] A method for using the external preparation composition according to [1] above, which comprises the following steps (I) and (II) in order.
Step (I): Applying the external preparation composition to the object and then drying it to form a film made of the external preparation composition.Step (II): Bringing the coating into contact with a cleaning agent, and then Step of washing with water to remove the film

According to the present invention, it is possible to provide an external preparation composition containing a medicinal ingredient and capable of forming a film having excellent durability and moisture resistance, and a method for using the same.

[External preparation composition]
The present invention comprises the following components (A) to (D):
(A) a medicinal ingredient (B) a water-insoluble polymer (C) a non-volatile base (D) a volatile solvent; B2) It contains two or more selected from the group consisting of acrylic polymers and (B3) vinyl polymers, and the viscosity of the external preparation composition at 25° C. is 1.0 mPa·s or more and 10,000 mPa·s or less. The present invention relates to an external preparation composition. Hereinafter, the composition will also be referred to as the "composition of the present invention" as appropriate.

<Definition>
As used herein, the term "external preparation composition" refers to a composition that is mainly applied to the skin surface.
In this specification, "containing X" includes those in which X is blended.
In this specification, "water-insoluble polymer" means that 1 g of polymer is immersed in 10 g of ion-exchanged water in an environment of 23°C and 1 atm, and after 24 hours, more than 0.5 g of the immersed polymer does not dissolve. Refers to something that has properties.
In this specification, the term "non-volatile base" means that 1 g of the base is spread in a glass petri dish with a diameter of 48 mm, and the liquid state is maintained at 70 °C so that the mass loss rate after standing at 25 °C and normal pressure for 24 hours is less than 1%. refers to the base material that exhibits
A "volatile solvent" is one that has a mass loss rate of 1% or more after spreading 1 g of the solvent in a glass Petri dish with a diameter of 48 mm and leaving it at 25°C and normal pressure for 24 hours, is liquid at 25°C, and is other than water. means the ingredients of
In addition, in this specification, "film coating" refers to the fact that a coating is formed by applying an external preparation composition to a subject (the subject's skin), and that the coating is difficult to rub off even when the subject performs daily activities. It is said to have high durability. In addition, the fact that the coating does not easily twist or peel off even when rubbed under high temperature and high humidity conditions is referred to as "high moisture resistance of the coating." The durability and moisture resistance of the coating can be specifically evaluated by the method described in the Examples.

The composition of the present invention contains component (A): medicinal ingredient, component (B): water-insoluble polymer, component (C): nonvolatile base, and component (D): volatile solvent, Component (A) is a component that is not included in any of the other components (B), component (C), or component (D), and component (B) is not included in any of component (C) or component (D). It is also a component that does not contain

By having the above structure, the composition of the present invention can form a film that contains a medicinal ingredient and has excellent durability and moisture resistance. The reason for this is not certain, but it is thought to be as follows.
The composition of the present invention is a film-forming composition containing a water-insoluble polymer as component (B) and a nonvolatile base as component (C) as film-forming components. When the composition of the present invention is applied to the skin and then dried, component (D) evaporates and a film containing components (A) to (C) is formed.
Since component (B) is water-insoluble and can form a highly hydrophobic film, it is thought that the durability and moisture resistance of the film can be easily improved, and the stickiness of the film can be suppressed. On the other hand, if only component (B) is used as a film-forming component, there is a concern that the film will become brittle and its durability will decrease. In the present invention, it is thought that these problems could be suppressed by using component (B) and component (C) together.
Furthermore, when only one type of water-insoluble polymer is used as component (B), or when only the same type of polymer is used even if there are two or more types of water-insoluble polymers, not only the durability of the coating but also It has been found that it is difficult to achieve a high level of moisture resistance in which the film does not twist or peel even when rubbed under high temperature and high humidity conditions. In the present invention, it is considered that the above problem can be solved by using two or more specific and different types of water-insoluble polymers as component (B).

It is believed that component (D) contributes to improving the quick drying properties of the external preparation composition, the crystallization suppressing effect of component (A), and the like. By suppressing the crystallization of component (A) in the coating, component (A), which is a medicinal component, can be effectively sustained-released into the target object. Furthermore, when the external preparation composition contains component (D), it becomes easier to adjust the viscosity within a predetermined range. As a result, it is thought that the applicability and film-forming properties of the external preparation composition are improved, and the durability and moisture resistance of the formed film are also further improved.

In addition, the coating formed by the composition of the present invention has less stickiness, has excellent durability and moisture resistance during use, and can be easily removed by washing with water using a detergent (hereinafter referred to as "coating"). (also called "removability").

<Ingredient (A): Medicinal ingredient>
The composition of the present invention contains a medicinal ingredient as component (A). From the viewpoint of use in an external preparation composition, component (A) is preferably a skin external drug component that can be administered transdermally. Specifically, component (A) includes an anti-inflammatory analgesic ingredient, a local irritation ingredient, a blood circulation promoting ingredient, an antihistamine ingredient, a herbal medicine ingredient, an anti-pruritic ingredient, a local anesthetic ingredient, a keratin softening ingredient, a bactericidal ingredient, an antibacterial/antifungal ingredient, It preferably contains one or more selected from the group consisting of an immunosuppressant, an antiviral component, a hair growth/hair growth component, a sebum suppressing component, an antiperspirant component, and a whitening component, and includes an anti-inflammatory analgesic component, an antihistamine component, and an antipruritic component. , a bactericidal component, an antibacterial/antifungal component, an immunosuppressant, an antiviral component, a hair growth/hair growth component, a sebum suppressing component, an antiperspirant component, and a whitening component. .

Anti-inflammatory and analgesic ingredients include glycol salicylate, methyl salicylate, aspirin, sulpirin hydrate, acetaminophen, diclofenac sodium, fenbufen, ibuprofen, aminoprofen, loxoprofen sodium hydrate, naproxen, oxaprofen, ketoprofen, and tiaprofen acid. , sulindac, aluminum flufenamate, felbinac, mefenamic acid, indomethacin, indomethacin farnesil, acemethacin, proglumethacin maleate, bendazac, piroxicam, ampiroxicam, lornoxicam, tenoxicam, meloxicam, etodolac, tiaramide hydrochloride, bucolome, flurubi Profen, esflurbiprofen, lysozyme hydrochloride, bromelain, diphenhydramine hydrochloride, dibucaine, dimethylisopropylazulene, benzethonium chloride, glycyrrhizic acid, dipotassium glycyrrhizinate, zinc oxide, allantoin, heparin analog, glycyrrhetinic acid, ibuprofen piconol , fluocinolone acetonide, difluprednate, clobetasol propionate, betamethasone valerate, and the like. Among these, glycol salicylate, methyl salicylate, diclofenac sodium, loxoprofen sodium hydrate, ketoprofen, indomethacin, piroxicam, flurbiprofen, esflurbiprofen, glycyrrhizic acid, dipotassium glycyrrhizinate, zinc oxide, allantoin, heparin At least one selected from the group consisting of similar substances, glycyrrhetinic acid, ibuprofen piconol, fluocinolone acetonide, difluprednate, clobetasol propionate, and betamethasone valerate is preferred.

Local irritation ingredients include l-menthol, dl-camphor, nonylic acid vanillylamide, ammonia, peppermint oil, and the like. Among these, one or more selected from the group consisting of l-menthol, dl-camphor, and nonylic acid vanillylamide are preferred.

Examples of the blood circulation promoting component include benzyl nicotinate, sodium polyethylene sulfonate, tocopherol acetate, carpronium chloride hydrate, and the like. Among these, one or more selected from the group consisting of tocopherol acetate and carpronium chloride hydrate are preferred.

Examples of the antihistamine component include diphenhydramine, diphenhydramine hydrochloride, diphenhydramine salicylate, chlorpheniramine maleate, and the like. Among these, one or more selected from the group consisting of diphenhydramine, diphenhydramine hydrochloride, and chlorpheniramine maleate are preferred.

Herbal medicine ingredients include chili pepper, arnica tincture, eucalyptus oil, auricularia japonica, arnica tincture, juyaku, peony, mugwort, keihi, nebula, kobushi, sojutsu, radish, quince, chimpi, carrot, magrot, clove, ginger, sardine, Examples include daylily, fennel, osmanthus, koka, koubo, spruce, and inch. Among these, one or more selected from the group consisting of chili pepper and arnica tincture are preferred.

Anti-pruritic ingredients include crotamiton, cortisone acetate, isothipendyl hydrochloride, benzalkonium chloride, calamine, d-borneol, aqueous ammonia, hydrocortisone, hydrocortisone acetate, hydrocortisone butyrate, dexamethasone, dexamethasone acetate, prednisolone, prednisolone acetate. ester, prednisolone valerate acetate, ufenamate, and the like. Among these, one or more selected from the group consisting of crotamiton, benzalkonium chloride, hydrocortisone, hydrocortisone acetate, hydrocortisone butyrate, dexamethasone, dexamethasone acetate, prednisolone, prednisolone valerate acetate, and ufenamate are preferred. .

Local anesthetic ingredients include lidocaine, mepivacaine, bupivacaine, ropivacaine, levopupivacaine, dibucaine, dibucaine hydrochloride, ethyl aminobenzoate, and the like. Among these, one or more selected from the group consisting of lidocaine and dibucaine hydrochloride are preferred.

Examples of keratin softening ingredients include urea, sulfur, and salicylic acid.

Antibacterial ingredients include chlorhexidine gluconate, sodium copper chlorophyllin, isopropylmethylphenol, cetylpyridinium chloride hydrate, benzethonium chloride, benzalkonium chloride, resorcinol, acrinol hydrate, chlorhexidine gluconate, homosulfamine, and homosulfamine. Examples include sulfamine hydrochloride, povidone iodine, iodine/potassium iodide, mercurochrome, oxidol, cresol, iodoform, thymol, chlorhexidine hydrochloride, adapalene, trichlorocarbanilide, and the like. Among these, one or more selected from the group consisting of isopropylmethylphenol, benzethonium chloride, resorcinol, homosulfamine, homosulfamine hydrochloride, chlorhexidine hydrochloride, adapalene, and trichlorocarbanilide are preferred.

Antibacterial and antifungal ingredients include undecylenic acid, zinc undecylenate, phenyl-11-iodo-10-undecinoate, exalamide, clotrimazole, econazole nitrate, miconazole nitrate, tioconazole, zinc diethyldithiocarbamate, ciclopirox olamine, and siccanin. , trichomycin, pyrrolnitrin, thianthol, 2,4,6-tribromphenylcaproic acid ester, trimethylcetylammonium pentachlorophenate, tolcyclate, tolnaftate, haloprozin, tree bark, berberine benzoate, dequalinium chloride, chlorhexidine hydrochloride, Chlorhexidine gluconate solution, dequalinium acetate, hinokitiol, lebrucin, benzoic acid, chlorobutanol, acetic acid, phenol, iodine tincture, diphenylpyraline hydrochloride, diphenhydramine salicylate, diphenylimidazole, chlorpheniramine maleate, dibucaine hydrochloride, procaine hydrochloride, lidocaine hydrochloride, aldioxa , glycyrrhizic acid and its salts, shicon, turmeric, ronin, diethyl phthalate, chlorhydroxyaluminum, penicillins, cephems, carbapenems, monobactams, penems, aminoglycosides, fosfomycins, chloramphenicols, macrolides glycopeptides, quinolones, new quinolones, sulfa drugs, fradiomycin sulfate, gentamicin sulfate, pentamidine isethionate, silver sulfadiazine, oxiconazole nitrate, sulconazole nitrate, bifonazole, neticonazole hydrochloride, lanoconazole, tenafine hydrochloride salts, amorolfine hydrochloride, terbinafine hydrochloride, butenafine hydrochloride, polymyxin B sulfate, colistin sulfate, bacitracin, fradiomycin sulfate, benzoyl peroxide, nadifuroxan, levofloxan, clindamycin phosphate, and the like. Among these, one or more selected from the group consisting of clotrimazole, miconazole nitrate, pyrrolnitrine, tolnaftate, hinokitiol, fradiomycin sulfate, oxiconazole nitrate, bifonazole, lanoconazole, terbinafine hydrochloride, and butenafine hydrochloride. is preferred.

Immunosuppressants include tacrolimus and the like.

Antiviral components include acyclovir, vidarabine, and the like.

Hair growth/hair growth ingredients include minoxidil, panthenol, pantothenyl ethyl ether, and the like.

Examples of sebum suppressing ingredients include pyridoxine hydrochloride and the like.

Examples of antiperspirant components include aluminum chloride, glycopyrronium tosylate hydrate, sofpironium bromide, and the like.

Examples of whitening ingredients include tranexamic acid, tretinoin, and hydroquinone.

As component (A), one or more of the above medicinal ingredients can be used.
Among the above, component (A) is glycol salicylate, methyl salicylate, diclofenac sodium, loxoprofen sodium hydrate, ketoprofen, indomethacin, flurbiprofen, dipotassium glycyrrhizinate, zinc oxide, allantoin, heparin-like substance, glycyrrhetinic acid. , ibuprofen piconol, fluocinolone acetonide, l-menthol, dl-camphor, nonylic acid vanillylamide, tocopherol acetate, carpronium chloride hydrate, diphenhydramine, diphenhydramine hydrochloride, chlorpheniramine maleate, capsicum, crotamiton , benzalkonium chloride, hydrocortisone, hydrocortisone butyrate, dexamethasone acetate, prednisolone valerate acetate, betamethasone valerate, ufenamate, lidocaine, dibucaine hydrochloride, urea, sulfur, salicylic acid, isopropylmethylphenol, benzethonium chloride , resorcin, homosulfamine, homosulfamine hydrochloride, chlorhexidine hydrochloride, trichlorocarbanilide, clotrimazole, miconazole nitrate, tolnaftate, hinokitiol, oxiconazole nitrate, bifonazole, lanoconazole, terbinafine hydrochloride, butenafine hydrochloride, tacrolimus, 1 selected from the group consisting of acyclovir, vidarabine, minoxidil, panthenol, pantothenyl ethyl ether, pyridoxine hydrochloride, tranexamic acid, tretinoin, homosulfamine hydrochloride, aluminum chloride, glycopyrronium tosylate hydrate, and sofpironium bromide It is more preferable to include more than one species.

<Component (B): Water-insoluble polymer>
The composition of the present invention contains a water-insoluble polymer as component (B). Component (B) is a film-forming component, and is considered to improve the film-forming properties of the composition, making it possible to form a film with high durability and moisture resistance. Furthermore, even when component (A) with high crystallinity is used, crystallization of component (A) in the coating can be suppressed, and the coating formed is less sticky and can be washed with water using a detergent. This also has the effect that it can be easily removed.

From the viewpoint of improving film-forming properties, component (B) is preferably a film-forming water-insoluble polymer. In addition, the definition of "water-insoluble" of component (B) is as described above.

Component (B) contains two or more selected from the group consisting of (B1) cellulose polymer, (B2) acrylic polymer, and (B3) vinyl polymer.
In this specification, "component (B) contains two or more selected from the group consisting of (B1) cellulose polymer, (B2) acrylic polymer, and (B3) vinyl polymer" specifically means means any of the embodiments (i) to (iv) below.
(i) Component (B) contains component (B1) and component (B2) and does not contain component (B3) (ii) Component (B) contains component (B1) and component (B3) and does not contain component (B2). ) does not contain (iii) component (B) contains component (B2) and component (B3) and does not contain component (B1) (iv) component (B) contains component (B1), component (B2), and Contains component (B3) Therefore, for example, if component (B) contains two or more types of component (B1) but does not contain either component (B2) or component (B3), it is not included in the scope of the present invention. shall be.
Among the above embodiments, embodiment (i) or (iv) is preferable from the viewpoint of improving the durability and moisture resistance of the coating, improving the effect of suppressing crystallization of component (A), and suppressing stickiness of the coating. Embodiment (i) is preferred, and embodiment (i) is more preferred.

(Component (B1): cellulose polymer)
Examples of the cellulose polymer used as component (B1) include water-insoluble polymers having a cellulose skeleton.
Specific examples of component (B1) include methylcellulose, ethylcellulose, hypromellose, carboxymethylcellulose, carboxymethylethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hypromellose phthalate, hydrophobized (C16-18) hydroxypropylmethylcellulose, and hypromellose acetate. Among ester succinates, cellulose acetates, and the like, water-insoluble ones can be used, and one or more of these can be used.

From the viewpoint of improving the durability and moisture resistance of the film, improving the crystallization suppressing effect of component (A), and suppressing stickiness of the film, component (B1) includes ethyl cellulose, hypromellose phthalate, and hydrophobized (C16-18) hydroxypropyl methylcellulose are preferred, and hypromellose phthalate is more preferred.

A commercially available product can also be used as component (B1). For example, the ethylcellulose used as component (B1) is "Ethocel 100P" manufactured by Nissin Kasei Co., Ltd., and the hypromellose phthalate ester is "HPMCP HP-55" and "HPMCP HP-" manufactured by Shin-Etsu Chemical Co., Ltd. 55S", "HPMCP HP-50", etc.

(Component (B2): Acrylic polymer)
Examples of the acrylic polymer used as component (B2) include water-insoluble polymers containing at least a structural unit derived from a monomer having a (meth)acrylic group. In this specification, "(meth)acrylic" means both acrylic and methacryl.
Specific examples of component (B2) include (acrylates/diacetone acrylamide) copolymer, acrylamide/methacrylate methoxypolyethylene glycol copolymer, alkyl acrylate copolymer, and acrylic ester/vinyl acetate copolymer. , 2-ethylhexyl acrylate/methyl acrylate/acrylic acid/glycidyl methacrylate copolymer, 2-ethylhexyl acrylate/vinyl acetate/hydroxyethyl acrylate/glycidyl methacrylate copolymer, 2-ethylhexyl acrylate/diacetone Acrylamide/acetoacetoxyethyl methacrylate/methyl methacrylate copolymer, 2-ethylhexyl acrylate/vinylpyrrolidone copolymer, 2-ethylhexyl acrylate/2-ethylhexyl methacrylate/dodecyl methacrylate copolymer, ethyl acrylate/ Water-insoluble ones among methyl methacrylate copolymers, ethyl acrylate/methyl methacrylate/trimethylammonium ethyl methacrylate copolymers, methyl methacrylate/butyl methacrylate/dimethylaminoethyl methacrylate copolymers, etc. Among these, one type or two or more types can be used.

Among the above, the (acrylates/diacetone acrylamide) copolymer is indicated by the cosmetic ingredient display name "(alkyl acrylate/diacetone acrylamide) copolymer AMP", and the acrylamide/methacrylate methoxypolyethylene glycol copolymer is indicated by the pharmaceutical ingredient display name "(alkyl acrylate/diacetone acrylamide) copolymer AMP". "Acrylic acid amide/methacrylic acid methoxypolyethylene glycol copolymer liquid" listed in Additive Standards 2018 (Ministry of Health, Labor and Welfare, Pharmaceutical and Environmental Health Bureau, Drug Review Management Division) is used as an alkyl acrylate copolymer under the cosmetic ingredient display name ""Alkyl acrylate copolymer ammonium" and 2-ethylhexyl acrylate/vinylpyrrolidone copolymer include "2-ethylhexyl acrylate/vinylpyrrolidone copolymer" as described in the Pharmaceutical Excipients Standards 2018 (Ministry of Health, Labor and Welfare, Pharmaceutical and Environmental Health Bureau, Drug Review Management Division). 2-ethylhexyl acrylate/2-ethylhexyl methacrylate/dodecyl methacrylate copolymer is called ``2-ethylhexyl acrylate/2-ethylhexyl methacrylate/dodecyl methacrylate copolymer solution.'' For the ethyl acrylate/methyl methacrylate copolymer, "ethyl acrylate/methyl methacrylate copolymer dispersion" is used, and for the methyl methacrylate/butyl methacrylate/dimethylaminoethyl methacrylate copolymer, "aminoalkyl methacrylate" is used. Copolymer E' can be used, respectively.
Furthermore, as the ethyl acrylate/methyl methacrylate/trimethylammonium ethyl methacrylate copolymer, "aminoalkyl methacrylate copolymer RS", which is known as a pharmaceutical additive, can be used.

From the viewpoint of improving the durability and moisture resistance of the film, improving the crystallization suppressing effect of component (A), and suppressing stickiness of the film, as component (B2), (acrylates/diacetone acrylamide) copolymer Combination is more preferred.

A commercially available product can also be used as component (B2). For example, the (acrylates/diacetone acrylamide) copolymer used as component (B2) is "Plus Size L-53" manufactured by Gooh Kagaku Kogyo Co., Ltd., and the alkyl acrylate/vinyl acetate copolymer is Daido Kasei Kogyo Co., Ltd. Examples of the alkyl acrylate copolymer include "Vinisol 2140L" manufactured by Co., Ltd., and "Vinisol 1086WP" manufactured by Daido Kasei Kogyo Co., Ltd.

(Component (B3): vinyl polymer)
Examples of the vinyl polymer used as component (B3) include water-insoluble polymers that do not belong to the acrylic polymers and that include at least a structural unit derived from a monomer having a vinyl group. Examples of the vinyl polymer include water-insoluble ones such as polyvinyl alcohol, polyvinyl acetate, and polyvinyl butyral.
Polyvinyl butyral is preferred as component (B3) from the viewpoint of improving the durability and moisture resistance of the coating, improving the effect of suppressing crystallization of component (A), and suppressing stickiness of the coating.

A commercially available product can also be used as component (B3). For example, the polyvinyl butyral used as component (B3) includes the "S-LEC B/K" series manufactured by Sekisui Chemical Co., Ltd., and the like.

(i) When component (B) contains component (B1) and component (B2) but does not contain component (B3), component (B1) preferably contains ethylcellulose, hypromellose phthalate, and hydrophobized (C16-18) One or more selected from the group consisting of hydroxypropyl methyl cellulose, more preferably hypromellose phthalate, and component (B2) is preferably (acrylates/diacetone acrylamide) copolymer. .
(ii) In the case where component (B) contains component (B1) and component (B3) but does not contain component (B2), component (B1) is preferably hypromellose phthalate and component (B3) is , preferably polyvinyl butyral.
(iii) In the case where component (B) contains component (B2) and component (B3) but does not contain component (B1), component (B2) is preferably a (acrylates/diacetone acrylamide) copolymer, component (B3) is preferably polyvinyl butyral.
(iv) In the case where component (B) includes component (B1), component (B2), and component (B3), component (B1) is preferably hypromellose phthalate, and component (B2) is preferably (acrylates/diacetone acrylamide) copolymer, component (B3) is preferably polyvinyl butyral.

When component (B) contains component (B1) and component (B2), the mass ratio of component (B2) to component (B1) [(B2)/(B1)] is the one that improves the durability and moisture resistance of the coating. From this point of view, it is preferably 0.05 or more, more preferably 0.1 or more, even more preferably 0.2 or more, even more preferably 0.5 or more, even more preferably 1.0 or more, and the From the viewpoint of improving durability and moisture resistance, and suppressing stickiness of the film, it is preferably 30 or less, more preferably 20 or less, even more preferably 15 or less, even more preferably 12 or less, even more preferably 10 or less.

When component (B) contains component (B1) and component (B3), the mass ratio of component (B3) to component (B1) [(B3)/(B1)] is the one that improves the durability and moisture resistance of the coating. From this point of view, it is preferably 0.1 or more, more preferably 0.2 or more, even more preferably 0.5 or more, even more preferably 1.0 or more, even more preferably 2.0 or more, and the From the viewpoint of improving durability and moisture resistance, and suppressing stickiness of the film, it is preferably 20 or less, more preferably 15 or less, even more preferably 12 or less, even more preferably 10 or less, even more preferably 8 or less.

When component (B) includes component (B2) and component (B3), the mass ratio of component (B2) to component (B3) [(B2)/(B3)] is a factor that improves the durability and moisture resistance of the coating. From this point of view, it is preferably 0.05 or more, more preferably 0.1 or more, even more preferably 0.2 or more, even more preferably 0.5 or more, even more preferably 1.0 or more, and the From the viewpoint of improving durability and moisture resistance, and suppressing stickiness of the film, it is preferably 30 or less, more preferably 20 or less, even more preferably 15 or less, even more preferably 12 or less, even more preferably 10 or less.

Component (B) can also contain water-insoluble polymers other than component (B1), component (B2), and component (B3) within a range that does not impair the effects of the present invention. However, from the viewpoint of improving the durability and moisture resistance of the film, improving the crystallization suppressing effect of component (A), and suppressing stickiness of the film, component (B1) and component (B2) in component (B) ), and the total content of component (B3) is preferably 50% by mass or more, more preferably 60% by mass or more, even more preferably 70% by mass or more, even more preferably 80% by mass or more, even more preferably 90% by mass or more. It is not less than 100% by mass and not more than 100% by mass.

<Component (C): Nonvolatile base>
The composition of the present invention contains a nonvolatile base (excluding those corresponding to component (A)) as component (C). It is thought that component (C), when used in combination with component (B), contributes to improving the durability and moisture resistance of the film, as well as improving the crystallization suppressing effect of component (A).
The definition of the "nonvolatile base" of component (C) is as described above.

Component (C) includes lipophilic bases, hydrophilic bases, amphiphilic bases, etc., and one or more of these can be used.

(Lipophilic base)
Preferable examples of the lipophilic base include polar oils, non-polar oils, and the like.
Specific examples of polar oils include non-volatile synthetic ester oils, including (i) fatty acid monoesters consisting of fatty acids and monohydric alcohols, (ii) fatty acid monoesters or diesters consisting of fatty acids and dihydric alcohols, (iii) one or more types selected from the group consisting of dicarboxylic acid diester consisting of dicarboxylic acid and monohydric alcohol, (iv) tricarboxylic acid triester consisting of tricarboxylic acid and monohydric alcohol, and (v) glycerin fatty acid triester is more preferable.

(i) Fatty acid monoesters consisting of fatty acids and monohydric alcohols include monoesters of saturated fatty acids having 8 to 22 carbon atoms and aliphatic or aromatic ring-containing monohydric alcohols having 1 to 24 carbon atoms. For example, cetyl octoate, cetyl 2-ethylhexanoate, ethyl laurate, hexyl laurate, isopropyl myristate, myristyl myristate, hexadecyl myristate, 2-hexyldecyl myristate, octyldodecyl myristate, isopropyl palmitate. , ethylhexyl palmitate, hexadecyl palmitate, 2-hexyldecyl palmitate, 2-heptylundecyl palmitate, butyl stearate, 2-ethylhexyl stearate, isocetyl stearate, isocetyl isostearate, isononyl isononanoate, isotridecyl isononanoate, Examples include hexyldecyl dimethyloctanoate.

(ii) The fatty acid monoester or diester consisting of a fatty acid and a dihydric alcohol is a monoester or diester of a saturated fatty acid having 8 to 22 carbon atoms and an aliphatic or aromatic dihydric alcohol having 1 to 12 carbon atoms. Examples include propylene glycol monocaprate, ethylene glycol di-2-ethylhexanoate, ethylene glycol dilaurate, ethylene glycol distearate, neopentyl glycol dicaprate, neopentyl glycol diethylhexanoate, di(caprylic acid) /capric acid) propanediol, diisostearate propanediol, and the like.

(iii) The dicarboxylic acid diester consisting of a dicarboxylic acid and a monohydric alcohol includes an aliphatic or aromatic dicarboxylic acid having 4 to 18 carbon atoms and an aliphatic or aromatic ring-containing monohydric alcohol having 1 to 24 carbon atoms. Examples include 2-ethylhexyl succinate, diisopropyl adipate, dibutyl adipate, diisobutyl adipate, 2-hexyldecyl adipate, di-2-heptylundecyl adipate, diethyl sebacate, and sebacic acid. Examples include diisopropyl, di-2-ethylhexyl sebacate, diisononyl phthalate, diisostearyl malate, and the like.

(iv) The tricarboxylic acid triester consisting of tricarboxylic acid and a monohydric alcohol includes an aliphatic or aromatic tricarboxylic acid having 5 to 12 carbon atoms, and an aliphatic or aromatic ring-containing monovalent tricarboxylic acid having 1 to 24 carbon atoms. Examples include triester with alcohol, such as triisodecyl trimellitate.

Examples of the (v) glycerin fatty acid triester include triesters of glycerin and saturated fatty acids having 8 to 22 carbon atoms, such as glycerin tri-2-ethylhexanoate, glycerin trimyristate, tri- Examples include glycerin 2-heptylundecanoate and tristearin.

Ester oils other than the above (i) to (v) include alkyl benzoate, cetyl lactate, myristyl lactate, lanolin acetate, dipentaerythritol fatty acid ester, glycerin di-2-heptylundecanoate, castor oil fatty acid methyl ester, N- Lauroyl-L-glutamate-2-octyldodecyl, etc. can also be used.

Among the above, the ester oil is one or more selected from the group consisting of (i) fatty acid monoesters consisting of fatty acids and monohydric alcohols, and (ii) fatty acid monoesters or diesters consisting of fatty acids and dihydric alcohols. is more preferable, a fatty acid monoester consisting of a fatty acid and a monohydric alcohol having 1 to 24 carbon atoms, and a saturated fatty acid having 8 to 22 carbon atoms, and an aliphatic or aromatic dihydric alcohol having 1 to 12 carbon atoms. More preferably, one or more selected from the group consisting of monoesters or diesters with and even more preferably one or more selected from the group consisting of isopropyl myristate and propylene glycol monocaprate.

Specific examples of non-polar oils include non-volatile hydrocarbon oils, silicone oils, fluorine oils, and the like. Examples of the hydrocarbon oil include liquid paraffin and squalane, and examples of the silicone oil include dimethylpolysiloxane, dimethylcyclopolysiloxane, methylphenylpolysiloxane, methylhydrogenpolysiloxane, and higher alcohol-modified organopolysiloxane. Examples of the fluorine oil include fluoropolyether, perfluoroalkyl ether silicone, and the like.

(Hydrophilic base)
The hydrophilic base preferably includes one or more selected from the group consisting of polyols and lower amines.
Specific examples of polyols include nonvolatile alkylene glycols, polyalkylene glycols, glycerin, and the like. Examples of the alkylene glycols include ethylene glycol, propylene glycol, 1,3-propanediol, 1,3-butylene glycol (1,3-butanediol), and 1,2-pentanediol; examples of the polyalkylene glycols include , diethylene glycol, dipropylene glycol, polyethylene glycol, polypropylene glycol, polyoxyethylene/polyoxypropylene glycol, etc. Examples of the glycerin include glycerin, diglycerin, triglycerin, and the like. It is preferable that polyethylene glycol, polypropylene glycol, and polyoxyethylene polyoxypropylene glycol have a weight average molecular weight of less than 10,000.

As used herein, the term "lower amine" refers to an amine having preferably 9 or less carbon atoms, more preferably 2 or more and 9 or less carbon atoms. The lower amine is preferably an alkanolamine from the viewpoint of non-volatility, improving the durability and moisture resistance of the coating, improving the effect of suppressing crystallization of component (A), and suppressing stickiness of the coating. preferable.
Specific examples of alkanolamines include triethanolamine, diethanolamine, monoethanolamine, triisopropanolamine, diisopropanolamine, monoisopropanolamine, 2-amino-2-methylpropanol, and the like.

(amphiphilic base)
As the amphipathic base, preferably an ionic or nonionic surfactant is mentioned, and a nonionic surfactant is preferred.
Specific examples of nonionic surfactants include polyoxyethylene alkyl ether, polyoxyethylene alkenyl ether, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene fatty acid ester, alkyl glucoside, alkyl glyceryl ether, Examples include fatty acid sucrose ester, polyoxyethylene hydrogenated castor oil, alkyl saccharide, alkylamine oxide, and alkylamidoamine oxide.
Alkyl groups in polyoxyethylene alkyl ethers, alkyl glucosides, alkyl glyceryl ethers, alkyl saccharides, alkyl amine oxides, and alkylamidoamine oxides, alkenyl groups in polyoxyethylene alkenyl ethers, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene fatty acids The fatty acid in the ester and fatty acid sucrose ester preferably has 8 to 22 carbon atoms, more preferably 10 to 20 carbon atoms, and even more preferably 12 to 18 carbon atoms.

Among the above, the nonionic surfactant is preferably one or more selected from the group consisting of polyoxyethylene sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene fatty acid ester, alkyl glucoside, and alkyl glyceryl ether. , polyoxyethylene sorbitan fatty acid ester is more preferred.
Specific examples of polyoxyethylene sorbitan fatty acid esters include polyoxyethylene sorbitan monolaurate (20E.O.) (polysorbate 20), polyoxyethylene sorbitan monostearate (20E.O.) (polysorbate 60), and tristearic acid. Examples include polyoxyethylene sorbitan (20E.O.) (polysorbate 65), polyoxyethylene sorbitan oleate (20E.O.) (polysorbate 80), and polyoxyethylene sorbitan oleate (20E.O.) is preferred. (Polysorbate 80).

Component (C) can be used alone or in combination of two or more.
Among the above, component (C) is preferably one or more selected from the group consisting of polar oils, non-polar oils, polyols, alkanolamines, and nonionic surfactants, such as isopropyl myristate, propylene glycol monocaprate, and squalane. , 1,3-butylene glycol, dipropylene glycol, polyethylene glycol with a weight average molecular weight of less than 1,000, triethanolamine, diisopropanolamine, 2-amino-2-methylpropanol, and polyoxyethylene sorbitan fatty acid ester. More preferably, one or more selected from the group consisting of isopropyl myristate, 1,3-butylene glycol, diisopropanolamine, 2-amino-2-methylpropanol, and polyoxyethylene sorbitan fatty acid ester. It is more preferable to include the above.

Note that the amine that is component (C) also includes the amine that constitutes the neutralized salt of the water-insoluble polymer that is component (B).
For example, in the composition of the present invention, as a commercial product containing component (B) and alkanolamine as component (C), a portion of the (acrylates/diacetone acrylamide) copolymer with 2-amino-2-methylpropanol is used. It is also possible to use "Plus Size L-53P" manufactured by Gooh Kagaku Kogyo Co., Ltd., which contains a neutralized product.

<Component (D): volatile solvent>
The composition of the present invention contains a volatile solvent as component (D) (excluding those corresponding to component (A)). Component (D) contributes to improving the quick drying properties of the composition, the crystallization suppressing effect of component (A), and the like. Furthermore, by making it easier to adjust the viscosity of the external preparation composition to a predetermined range, it is thought that the applicability and film forming properties are improved, and the durability and moisture resistance of the formed film are further improved.
The definition of the "volatile solvent" of component (D) is as described above.

Component (D) includes volatile alcohols, ketones, esters, hydrocarbons, silicones, and the like.
The alcohol used as component (D) is preferably a lower alcohol. "Lower alcohol" is preferably an alcohol having 4 or less carbon atoms, and examples thereof include methanol, ethanol, n-propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutyl alcohol, sec-butyl alcohol, and tert-butyl alcohol. .
Ketones used as component (D) include acetone, ethyl methyl ketone, methyl isobutyl ketone, etc., esters include methyl acetate, ethyl acetate, butyl acetate, etc. hydrocarbons include volatile liquid paraffin, and silicones include linear Examples include polydimethylsiloxane and cyclic siloxane.

Component (D) can be used alone or in combination of two or more.
From the viewpoint of improving the coating properties and quick drying properties of the composition, the solubility or dispersibility of components (A) to (C), and the viewpoint of improving the crystallization suppressing effect of component (A), component (D) is preferable. is an alcohol having 4 or less carbon atoms, more preferably one or more selected from the group consisting of ethanol and isopropyl alcohol.

<Water>
It is preferable that the external preparation composition further contains water from the viewpoint of improving the effect of suppressing crystallization of component (A) and improving the removability of the film. The water used in the present invention is not particularly limited, and for example, ion exchange water, pure water, distilled water, etc. can be used.

<Water-soluble polymer>
The external preparation composition may further contain a water-soluble polymer to the extent that the effects of the present invention are not impaired. The water-soluble polymer is a water-soluble polymer that does not fall under any of the components (A) to (D), and includes, for example, carboxyvinyl polymer, polyacrylic acid, polyvinylpyrrolidone, and the like.
However, from the viewpoint of improving the durability and moisture resistance of the film, as well as suppressing stickiness of the film, it is preferable that the mass ratio of the water-soluble polymer to component (B) [water-soluble polymer/component (B)] is lower. Specifically, the mass ratio of the water-soluble polymer to component (B) in the external preparation composition [water-soluble polymer/component (B)] is preferably 2 or less, more preferably 1.5 or less, and even more preferably It is 1.3 or less, even more preferably 1 or less, even more preferably 0.5 or less, even more preferably 0.1 or less, and even more preferably 0.

<Other ingredients>
In addition to the above-mentioned components, the external preparation composition of the present invention may appropriately contain other components that are usually blended into external preparation compositions within a range that does not impair the object of the present invention. Examples of such components include organic acids or inorganic acids, antioxidants, ultraviolet absorbers, preservatives, pH adjusters other than organic or inorganic acids, fragrances, pigments, and the like.

<Content>
The content of each component in the external preparation composition is preferably as follows from the viewpoint of improving the durability and moisture resistance of the film, improving the crystallization suppressing effect of component (A), and suppressing stickiness of the film. It is as follows.

The content of component (A) in the external preparation composition is preferably 0.001% by mass or more, more preferably 0.005% by mass or more, and even more preferably is 0.01% by mass or more, more preferably 0.02% by mass or more, and from the viewpoint of improving the crystallization suppressing effect of component (A), preferably 30% by mass or less, more preferably 20% by mass or less, More preferably it is 15% by mass or less, even more preferably 10% by mass or less.

When component (A) contains an anti-inflammatory and analgesic component, the content of the anti-inflammatory and analgesic component in the external preparation composition is preferably 0.01% by mass or more and 30% by mass or less, more preferably 0.02% by mass or more and 20% by mass. % or less, more preferably 0.05 mass% or more and 15 mass% or less, even more preferably 0.05 mass% or more and 10 mass% or less, even more preferably 0.05 mass% or more and 6.0 mass% or less. .

When component (A) contains a local irritation component, the content of the local irritation component in the external preparation composition is preferably 0.001% by mass or more and 20% by mass or less, more preferably 0.005% by mass or more and 15% by mass. % or less, more preferably 0.01% by mass or more and 10% by mass or less, even more preferably 0.01% by mass or more and 6.0% by mass or less.

When component (A) contains a blood circulation promoting component, the content of the blood circulation promoting component in the external preparation composition is preferably 0.1% by mass or more and 30% by mass or less, more preferably 0.5% by mass or more and 20% by mass. % or less, more preferably 1.0% by mass or more and 15% by mass or less, even more preferably 1.0% by mass or more and 5.0% by mass or less.

When component (A) contains an antihistamine component, the content of the antihistamine component in the external preparation composition is preferably 0.01% by mass or more and 30% by mass or less, more preferably 0.02% by mass or more and 20% by mass. % or less, more preferably 0.05 mass% or more and 15 mass% or less, even more preferably 0.05 mass% or more and 10 mass% or less, even more preferably 0.1 mass% or more and 5.0 mass% or less, and more More preferably, it is 0.1% by mass or more and 3.0% by mass or less.

When component (A) contains a crude drug component, the content of the crude drug component in the external preparation composition is preferably 0.01% by mass or more and 30% by mass or less, more preferably 0.02% by mass or more and 20% by mass or less. , more preferably 0.05% by mass or more and 15% by mass or less, even more preferably 0.05% by mass or more and 10% by mass or less, even more preferably 0.1% by mass or more and 5.0% by mass or less, even more preferably is 0.1% by mass or more and 3.0% by mass or less.

When component (A) contains an antipruritic component, the content of the antipruritic component in the external preparation composition is preferably 0.01% by mass or more and 30% by mass or less, more preferably 0.02% by mass or more and 20% by mass or less. , more preferably 0.02% by mass or more and 15% by mass or less, even more preferably 0.02% by mass or more and 10% by mass or less.

When component (A) contains a local anesthetic component, the content of the local anesthetic component in the external preparation composition is preferably 0.01% by mass or more and 30% by mass or less, more preferably 0.02% by mass or more and 20% by mass. % or less, more preferably 0.02 mass% or more and 15 mass% or less, even more preferably 0.02 mass% or more and 10 mass% or less, even more preferably 0.02 mass% or more and 5.0 mass% or less. .

When component (A) contains a keratin softening component, the content of the keratin softening component in the external preparation composition is preferably 0.1% by mass or more and 30% by mass or less, more preferably 0.2% by mass or more and 20% by mass. % or less, more preferably 0.5% by mass or more and 20% by mass or less.

When component (A) contains a bactericidal component, the content of the bactericidal component in the external preparation composition is preferably 0.001% by mass or more and 20% by mass or less, more preferably 0.005% by mass or more and 15% by mass or less. , more preferably 0.01% by mass or more and 10% by mass or less, even more preferably 0.01% by mass or more and 5.0% by mass or less, even more preferably 0.01% by mass or more and 3.0% by mass or less. .

When component (A) contains an antibacterial/antifungal component, the content of the antibacterial/antifungal component in the external preparation composition is preferably 0.001% by mass or more and 20% by mass or less, more preferably 0.005% by mass. % or more and 15% by mass or less, more preferably 0.01% by mass or more and 10% by mass or less, even more preferably 0.02% by mass or more and 5.0% by mass or less, even more preferably 0.05% by mass or more3. It is 0% by mass or less.

When component (A) contains an immunosuppressant, the content of the immunosuppressant in the external preparation composition is preferably 0.01% by mass or more and 1% by mass or less, more preferably 0.03% by mass or more and 0.01% by mass or less. It is 5% by mass or less.

When component (A) contains an antiviral component, the content of the antiviral component in the external preparation composition is preferably 0.1% by mass or more and 20% by mass or less, more preferably 0.5% by mass or more and 15% by mass. % or less, more preferably 1.0% by mass or more and 10% by mass or less, even more preferably 1.0% by mass or more and 5.0% by mass or less.

When component (A) contains a hair growth/hair growth component, the content of the hair growth/hair growth component in the external preparation composition is preferably 0.1% by mass or more and 20% by mass or less, more preferably 0.5% by mass. % or more and 15% by mass or less, more preferably 1.0% by mass or more and 10% by mass or less, even more preferably 1.0% by mass or more and 5.0% by mass or less.

When component (A) contains a sebum-suppressing component, the content of the sebum-suppressing component in the external preparation composition is preferably 0.001% by mass or more and 20% by mass or less, more preferably 0.005% by mass or more and 15% by mass. % or less, more preferably 0.01 mass% or more and 10 mass% or less, even more preferably 0.01 mass% or more and 5.0 mass% or less, even more preferably 0.01 mass% or more and 3.0 mass% or less It is.

When component (A) contains an antiperspirant component, the content of the antiperspirant component in the external preparation composition is preferably 0.1% by mass or more and 20% by mass or less, more preferably 0.5% by mass or more and 15% by mass. % or less, more preferably 1.0% by mass or more and 10% by mass or less, even more preferably 2.0% by mass or more and 5.0% by mass or less.

When component (A) contains a whitening component, the content of the whitening component in the external preparation composition is preferably 0.01% by mass or more and 30% by mass or less, more preferably 0.02% by mass or more and 20% by mass or less. , more preferably 0.05% by mass or more and 15% by mass or less, even more preferably 0.1% by mass or more and 10% by mass or less, even more preferably 0.2% by mass or more and 5.0% by mass or less.

The content of component (B) in the external preparation composition is preferably 0.01% by mass or more, more preferably 0.05% by mass, from the viewpoint of improving film formation properties, and improving the durability and moisture resistance of the film. % or more, more preferably 0.1% by mass or more, even more preferably 0.5% by mass or more, even more preferably 1.0% by mass or more, from the viewpoint of improving the durability of the coating and suppressing stickiness of the coating. From this viewpoint, the content is preferably 30% by mass or less, more preferably 25% by mass or less, even more preferably 20% by mass or less, even more preferably 15% by mass or less, even more preferably 10% by mass or less.

When component (B) contains component (B1), the content of component (B1) in the external preparation composition is preferably 0.002% by mass or more, more preferably 0.005% by mass or more, and even more preferably 0.01% by mass or more, even more preferably 0.02% by mass or more, even more preferably 0.05% by mass or more, even more preferably 0.1% by mass or more, even more preferably 0.2% by mass or more The content is preferably 20% by mass or less, more preferably 15% by mass or less, even more preferably 10% by mass or less, even more preferably 8% by mass or less, even more preferably 5% by mass or less.

When component (B) contains component (B2), the content of component (B2) in the external preparation composition is preferably 0.003% by mass or more, more preferably 0.005% by mass or more, and even more preferably 0.01% by mass or more, even more preferably 0.02% by mass or more, even more preferably 0.05% by mass or more, even more preferably 0.1% by mass or more, even more preferably 0.2% by mass or more , even more preferably 0.4% by mass or more, even more preferably 0.5% by mass or more, even more preferably 0.6% by mass or more, and preferably 25% by mass or less, more preferably 20% by mass. % or less, more preferably 15% by mass or less, even more preferably 10% by mass or less, even more preferably 8% by mass or less.

When component (B) contains component (B3), the content of component (B3) in the external preparation composition is preferably 0.002% by mass or more, more preferably 0.005% by mass or more, and even more preferably 0.01% by mass or more, even more preferably 0.02% by mass or more, even more preferably 0.05% by mass or more, even more preferably 0.1% by mass or more, even more preferably 0.2% by mass or more , even more preferably 0.4% by mass or more, even more preferably 0.5% by mass or more, even more preferably 0.6% by mass or more, and preferably 20% by mass or less, more preferably 15% by mass. % or less, more preferably 10% by mass or less, even more preferably 8% by mass or less.

The content of component (C) in the external preparation composition is preferably 0.001% by mass or more, more preferably 0.005% by mass, from the viewpoint of improving film formation properties, and improving the durability and moisture resistance of the film. % or more, more preferably 0.01% by mass or more, even more preferably 0.05% by mass or more, even more preferably 0.1% by mass or more, and from the viewpoint of suppressing stickiness of the film, preferably 40% by mass. The content is more preferably 30% by mass or less, still more preferably 20% by mass or less, even more preferably 15% by mass or less.

The content of component (D) in the external preparation composition is preferably 10 It is at least 95% by mass, more preferably at least 20% by mass, even more preferably at least 30% by mass, even more preferably at least 40% by mass, and from the viewpoint of maintaining the coating properties and film forming properties of the composition. The content is at most 90% by mass, more preferably at most 80% by mass, even more preferably at most 70% by mass.

The total content of components (A) to (D) in the external preparation composition is determined from the viewpoints of improving the durability and moisture resistance of the film, improving the crystallization suppressing effect of component (A), and suppressing stickiness of the film. From the viewpoint of, preferably 20% by mass or more, more preferably 30% by mass or more, still more preferably 50% by mass or more, even more preferably 60% by mass or more, and 100% by mass or less, preferably 97% by mass. The content is preferably 95% by mass or less, further preferably 90% by mass or less.

When the external preparation composition contains water, the content of water in the external preparation composition is determined from the viewpoint of improving the applicability, film forming property, durability and moisture resistance of the external preparation composition, and component (A). From the viewpoint of improving crystallization suppressing effect, suppressing stickiness of the coating, and improving removability of the coating, preferably 1% by mass or more, more preferably 2% by mass or more, still more preferably 3% by mass or more, and more. More preferably 5% by mass or more, even more preferably 7% by mass or more, even more preferably 8% by mass or more, even more preferably 10% by mass or more, even more preferably 15% by mass or more, and the composition From the viewpoint of improving dryness, improving the durability and moisture resistance of the film, improving the effect of suppressing crystallization of component (A), and suppressing stickiness of the film, preferably 70% by mass or less, more preferably 60% by mass. % or less, more preferably 50% by mass or less, even more preferably 45% by mass or less, even more preferably 40% by mass or less, even more preferably 38% by mass or less, even more preferably 35% by mass or less.

The mass ratio [(A)/(B)] of component (A) to component (B) in the external preparation composition is determined from the viewpoint of fully expressing the efficacy of component (A) and from the viewpoint of crystallization of component (A). From the viewpoint of improving the suppressing effect, it is preferably 0.001 or more, more preferably 0.002 or more, and even more preferably 0.003 or more, and from the viewpoint of improving the coating properties and film forming properties of the composition, the durability of the film, and From the viewpoint of improving moisture resistance and improving the effect of suppressing crystallization of component (A), it is preferably 300 or less, more preferably 250 or less, even more preferably 200 or less, even more preferably 100 or less, and even more preferably 50. Hereinafter, it is even more preferably 30 or less, even more preferably 20 or less, even more preferably 10 or less, even more preferably 5 or less, even more preferably 2 or less.

The mass ratio [(A)/(C)] of component (A) to component (C) in the external preparation composition is determined from the viewpoint of fully expressing the efficacy of component (A) and from the viewpoint of crystallization of component (A). From the viewpoint of improving the suppressing effect, it is preferably 0.001 or more, more preferably 0.002 or more, even more preferably 0.003 or more, even more preferably 0.005 or more, even more preferably 0.01 or more, From the viewpoint of improving the coating properties and film forming properties of the composition, improving the durability and moisture resistance of the film, and improving the crystallization suppressing effect of component (A), preferably 100 or less, more preferably 80 or less, More preferably, it is 70 or less, even more preferably 60 or less, even more preferably 50 or less, even more preferably 45 or less.

The mass ratio [(C)/(B)] of component (C) to component (B) in the external preparation composition is preferably 0.01 or more, more preferably 0.01 or more, from the viewpoint of improving the durability and moisture resistance of the coating. is 0.02 or more, more preferably 0.03 or more, and is preferably 50 or less, more preferably 35 or less, and even more preferably It is 20 or less, even more preferably 10 or less, even more preferably 5.0 or less.

The mass ratio of component (A) to the total content of component (B) and component (C) in the external preparation composition [(A)/{(B)+(C)}] is the efficacy of component (A). From the viewpoint of sufficiently expressing , from the viewpoint of improving the durability and moisture resistance of the coating, and from the viewpoint of improving the crystallization suppressing effect of component (A), preferably 20 or less, more preferably 15 or less, still more preferably 10 or less, even more preferably 5. It is 0 or less, more preferably 4.0 or less, even more preferably 3.0 or less.

When the external preparation composition contains water, the mass ratio of water to component (D) in the external preparation composition [water/(D)] is determined from the viewpoint of improving the durability and moisture resistance of the coating, and the mass ratio of water to component (A) in the external preparation composition. From the viewpoint of improving the effect of suppressing crystallization, suppressing stickiness of the film, and improving removability of the film, it is preferably 0.005 or more, more preferably 0.05 or more, even more preferably 0.10 or more, and It is more preferably 0.20 or more, even more preferably 0.50 or more, from the viewpoint of improving the quick drying properties of the composition, the durability and moisture resistance of the coating, and the crystallization suppressing effect of component (A). From the viewpoint of suppressing stickiness of the coating, preferably 10 or less, more preferably 8.0 or less, even more preferably 5.0 or less, even more preferably 3.0 or less, even more preferably 2.0 or less, Even more preferably it is 1.0 or less, even more preferably 0.7 or less.

The mass ratio [(B)/(D)] of component (B) to component (D) in the external preparation composition is preferably 0.0001 or more, more preferably 0.0002, from the viewpoint of improving film formation properties. The above, more preferably 0.0005 or more, even more preferably 0.001 or more, and from the viewpoint of improving the coating properties and quick drying properties of the composition, preferably 1.0 or less, more preferably 0.50 or less, and Preferably it is 0.30 or less, even more preferably 0.20 or less, even more preferably 0.10 or less.

<Viscosity>
The viscosity of the external preparation composition at 25° C. is 1.0 mPa·s or more, preferably 1.5 mPa·s or more, more preferably 2.0 mPa·s or more, and Preferably it is 3.0 mPa·s or more. In addition, from the viewpoint of improving the quick-drying property of the composition and the durability and moisture resistance of the coating, it is 200,000 mPa·s or less, 150,000 mPa·s or less, and 130,000 mPa·s or less, 100,000 mPa・s or less, 50,000 mPa・s or less, 30,000 mPa・s or less, 20,000 mPa・s or less, 10,000 mPa・s or less, preferably 7,500 mPa・s・s or less, more preferably 5,000 mPa·s or less, even more preferably 3,000 mPa·s or less, even more preferably 2,000 mPa·s or less, even more preferably 1,000 mPa·s or less, even more preferably It is 700 mPa·s or less, even more preferably 500 mPa·s or less, even more preferably 200 mPa·s or less, even more preferably 100 mPa·s or less, even more preferably 50 mPa·s or less.
The viscosity at 25°C of the external preparation composition is the value measured by a vibration viscometer for compositions with a viscosity of 1,000 mPa/s or less, and with a B-type rotational viscometer for compositions with a viscosity of over 1,000 mPa/s. Specifically, it can be measured by the method described in Examples.

<Contact angle>
The external preparation composition preferably has a contact angle of 5° or more, more preferably 10° after 10 seconds of droplet deposition on artificial leather, from the viewpoint of improving the applicability of the composition, film forming property, and durability of the film. above, more preferably 15° or more, even more preferably 20° or more, even more preferably 25° or more, and preferably 80° or less, more preferably 75° or less, more preferably 70° or less, and Preferably it is 60° or less, more preferably 55° or less. In addition, the contact angle of the composition after 60 seconds of dropping on the artificial leather is preferably 5° or more, more preferably 10° or more, even more preferably 15° or more, even more preferably 20° or more, and Preferably it is 70° or less, more preferably 65° or less, more preferably 60° or less, more preferably 55° or less, even more preferably 50° or less.
In addition, the rate of change in the contact angle of the external preparation composition on artificial leather from 10 seconds after the droplet has been applied to 60 seconds after the droplet has been applied (1-((contact angle after 60 seconds after the droplet has been applied)/(contact angle after 10 seconds after the droplet has been applied) From the viewpoint of improving the coating properties of the composition, film forming properties, and durability of the film, the angle))) is preferably 0.6 or less, more preferably 0.5 or less, even more preferably 0.4 or less, and more. More preferably it is 0.3 or less, even more preferably 0.25 or less. The above contact angle can be measured at a temperature of 25° C. by the method described in Examples.

<Dosage form, etc.>
The external preparation composition of the present invention is preferably used as a skin external preparation composition.
The dosage form of the external preparation composition may be any form as long as it has a viscosity within the above range and is applicable to the skin. For example, lotion preparations, gel preparations, ointment preparations, cream preparations, or foam preparations made of the external preparation composition of the present invention; aerosol preparations or pump spray type preparations using the external preparation composition of the present invention; etc. Can be mentioned. Foamy preparations include preparations used by filling a pump former or the like with the external preparation composition of the present invention and discharging it in the form of a foam.
The compositions of the invention can also be electrostatically sprayed onto the skin using an electrostatic spray device. Electrostatic spray will be discussed later.

The aerosol formulation contains the external preparation composition and a propellant. Aerosol formulations using the external preparation composition of the present invention can provide a cooling sensation etc. by spraying the composition onto the skin and applying it.
In the aerosol formulation, the external preparation composition used as the aerosol stock solution and its preferred embodiments are the same as described above. That is, the content of components (A) to (D) in the aerosol stock solution and the viscosity of the aerosol stock solution are preferably within the above ranges.
Propellants used in aerosol formulations include liquefied petroleum gas (LPG), which is ethane, propane, normal butane, isobutane, isopentane, and mixtures thereof; ethers such as dimethyl ether (DME); compressed gases such as nitrogen and carbon dioxide. ; and the like, and one or more of these can be used.

In an aerosol preparation, the ratio of the external preparation composition, which is an aerosol stock solution, to the propellant is not particularly limited as long as it is possible to spray the external preparation composition onto the skin, but from the viewpoint of aerosol performance and the aerosol preparation. From the viewpoint of stability, the mass ratio of the external preparation composition to the propellant is preferably in the range of 1:0.01 to 1:10, more preferably 1:0.05 to 1:7.5. .
When the propellant is LPG, the mass ratio between the external preparation composition and LPG is more preferably 1:0.5 to 1:5, and when the propellant is dimethyl ether, the mass ratio between the external preparation composition and dimethyl ether is more preferably 1:0.5 to 1:5. The mass ratio of the external preparation composition to carbon dioxide is more preferably 1:0.1 to 1:5, and when the propellant is carbon dioxide, the mass ratio of the external preparation composition to carbon dioxide is more preferably 1:0.1. ~1:0.5.

Examples of aerosol containers used for aerosol preparations include known pressure-resistant containers made of metal or plastic, and double-layered containers in which an inner bag is housed inside the pressure-resistant container. In a double-structured container, it is preferable that the inner bag is filled with the external preparation composition, which is an aerosol stock solution, and the propellant is filled between the pressure-resistant container and the inner bag.

The method for preparing the aerosol formulation is not particularly limited. For example, it can be prepared by filling the aerosol container with the external preparation composition as an aerosol stock solution, attaching a valve, and then filling the propellant from the valve part.

Moreover, a pump spray type preparation is a preparation used by filling a pump spray container with the external preparation composition of the present invention.

[how to use]
The present invention also provides a method for using an external preparation composition, which has the following steps (I) and (II) in order.
Step (I): Applying the external preparation composition to the object and then drying it to form a film made of the external preparation composition.Step (II): Bringing the coating into contact with a cleaning agent, and then Step of washing with water to remove the film According to the method of the present invention, in step (I), the external preparation composition is applied to the object and then dried, thereby removing the component (A) which is a medicinal ingredient. A film containing the following can be formed on the surface of the object. Since the coating has excellent durability and moisture resistance, component (A) can be continuously released into the target object. Moreover, since the film can be washed away with water using a detergent, the film formed in step (I) can be easily removed from the object by performing step (II).

<Step (I)>
The method of applying the external preparation composition to the object in step (I) can be appropriately selected depending on the dosage form of the external preparation composition, for example, application by coating, casting, spraying, etc. There are several methods. Among these, it is preferable to apply by coating or spraying. After applying the external preparation composition, the component (D) is volatilized by natural drying or the like, and a film containing the components (A) to (C) is formed on the surface of the object.

When applying the external preparation composition directly to the skin, the external preparation composition can be applied by hand or using an applicator such as a metal roller, a plastic roller, a porous sponge, or a brush.
When spraying the external preparation composition onto the skin, methods for spraying the composition include methods using an aerosol, a pump spray, or an electrostatic spray device. Regarding aerosols and pump sprays, the above-mentioned aerosol formulations and pump spray formulations can be prepared using the external formulation composition as a stock solution, and the external formulation composition can be sprayed onto an object using the formulations.
Specifically, the electrostatic spray device includes a storage section that can accommodate the external preparation composition, a nozzle that discharges the external preparation composition, a power source that applies voltage to the nozzle, and a supply section that connects the nozzle from the storage section. and a means for delivering the external preparation composition. One embodiment thereof is a hand-held electrostatic spray device that has dimensions that allow it to be held with one hand.
As the electrostatic spray device, those exemplified in International Publication No. 2018/194140 etc. can be used.

The object to which the external preparation composition is applied is preferably the skin surface.
The application site of the external preparation composition is not particularly limited, but preferably includes the skin surface of the head, face, neck, hands, arms, feet, legs, buttocks, or torso.

The amount of the external preparation composition to be applied is not particularly limited, but from the viewpoint of effectively demonstrating the efficacy of component (A), it is preferably 0.5 μL/cm ² or more, more preferably 1 μL/cm ² or more, and even more preferably 3 μL. / ^cm2 or more. Further, from the viewpoint of the appearance (transparency) of the formed film, the amount is preferably 100 μL/cm ² or less, more preferably 50 μL/cm ² or less.

The drying method after applying the external preparation composition to the object is preferably natural drying, but a device such as a dryer can also be used as appropriate.

The thickness of the film formed in step (I) is preferably 0.005 mm or more, more preferably 0.01 mm or more, and even more preferably 0.005 mm or more, from the viewpoint of ease of forming the film and improving durability. It is .015 mm or more, more preferably 0.02 mm or more, and preferably 0.3 mm or less, more preferably 0.1 mm or less, still more preferably 0.07 mm or less, even more preferably 0.06 mm or less. . Specifically, the thickness of the coating can be measured by the method described in Examples.

<Step (II)>
In step (II), the coating formed in step (I) is brought into contact with a cleaning agent, and then washed with water to remove the coating.
Step (II) is preferably carried out after a certain period of time has elapsed since the coating was formed on the surface of the object in step (I), that is, after the efficacy of component (A) has been exerted. From this point of view, the time from step (I) to step (II) is preferably 0.5 hours or more and 72 hours or less, more preferably 1 hour or more and 48 hours or less.

The cleaning agent used in step (II) may be any cleaning agent for cleaning the object. Examples include detergents containing anionic, cationic, or nonionic surfactant components and detergents containing organic solvents. Specific examples thereof include synthetic detergents, soaps, and the like. When the target skin is the scalp, examples of the cleansing agent include shampoo, and when the target skin is the face, examples include facial cleansers. Other skin cleansers include soap, hand soap, body soap, and the like. Examples of the pH of the cleaning agent include less than pH 3 (acidic), pH 3 or more and 6 or less (weakly acidic), and pH greater than 6. From the viewpoint of removability of the film and the viewpoint of less irritation to the skin, the cleaning agent preferably has a pH of 3 or more and 6 or less (weakly acidic), or has a pH of more than 6, and more preferably has a pH of more than 6.
The pH of the detergent means the pH of a 5% aqueous solution at 20°C.
An embodiment of a method for removing the film formed on the skin surface in step (II) will be described. First, the cleaning agent is brought into contact with the film formed on the skin surface by coating, casting, spraying, or the like. When the detergent is a solid detergent such as soap, it is preferable to wet the coating on the skin surface or the solid detergent with water in advance and then bring the two into contact. Alternatively, the cleaning agent may be lathered in advance and then brought into contact with the coating.
After the cleaning agent that has been in contact with the coating is blended into the coating, it is washed with water. When washing with water, it is preferable to scrub it. This operation allows the film to be easily removed.

EXAMPLES Hereinafter, the present invention will be explained with reference to examples, but the present invention is not limited to the scope of the examples. In this example, various measurements and evaluations were performed by the following methods.

(viscosity)
The viscosity of the external preparation composition at 25°C was measured using a vibration viscometer (“VM-10AL” manufactured by Sekonic Co., Ltd.).For compositions with a viscosity exceeding 1,000 mPa・s, type B It was measured using a rotational viscometer (“TVB-10” manufactured by Toki Sangyo Co., Ltd., SPINDLE: M3, rotation speed: 12 rpm).

(Presence or absence of crystals in the coating)
18 μL of the external preparation composition was applied to an area of 1.5 cm x 2 cm on a slide glass using a Microman (manufactured by Gilson), and a hot plate (“Ceramic Hot Plate” manufactured by As One Co., Ltd.) set at 32°C was applied. ) for 1 hour. The presence or absence of crystals in the formed film was evaluated by observation with a polarizing microscope, and judgment was made based on the following criteria. A higher score means that precipitation of crystalline medicinal ingredients is less likely to occur.
5: No crystals are observed at all, 4: Crystals of less than about 10 μm are observed, 3: Crystals of about 10 μm or more and less than 50 μm are observed, 2: Crystals of about 50 μm or more and less than 100 μm are observed. 1: Crystals of approximately 100 μm or more are observed.

(sticky feeling of film)
An expert panelist applied 18 μL of the external preparation composition to an area of 1.5 cm x 2 cm on the inner side of the forearm using a Microman (manufactured by Gilson), and evaluated the sticky feeling on a 5-point scale after 2 minutes had elapsed. The average score of the six expert panelists (rounded to the second decimal place) is shown in the table. It means that the higher the score, the better the evaluation result.
5: Not sticky at all, 4: Slightly sticky, 3: Slightly sticky, 2: Sticky, 1: Very sticky

(Durability of film)
An expert panelist applied 18 μL of the external preparation composition to an area of 1.5 cm×2 cm on the inner side of the forearm using Microman (manufactured by Gilson). After application, the subjects performed daily activities at an exercise intensity of 3 METs or less in a room at 30° C. or lower, and the formed film was visually observed after a certain period of time to confirm whether or not the film remained. The longest time during which 90% or more of the film remained was scored according to the following criteria.
5: 8 hours later, 4: 4 hours later, 3: 1 hour later, 2: 30 minutes later, 1: 10 minutes later

(Moisture resistance of film)
An expert panelist applied 50 μL of the external preparation composition to an area of 2 cm x 2 cm on the inner side of the forearm using a Microman (manufactured by Gilson), and allowed it to air dry for 10 minutes. After that, rest for 10 minutes in a constant temperature and humidity room at a temperature of 40°C and humidity of 75%, and visually observe the remaining state of the film when rubbing the applied area with your finger 10 times, and judge the moisture resistance of the film using the following criteria. I did it.
5: There is no twisting or peeling at all, and 100% of the coating remains; 4: There is almost no twisting or peeling, and over 90% of the coating remains; 3: There is slight twisting or peeling, and over 80% of the coating remains; 2: There is some twisting and peeling, and 50% or more and less than 80% of the coating remains, 1: There is considerable twisting and peeling, and less than 50% of the coating remains.

Examples 1 to 102, Comparative Examples 1 to 8 (preparation and evaluation of external preparation compositions)
Component (B) and other components listed in the table were mixed with component (C), component (D), and an appropriate amount of water, and then component (A) was mixed. Thereafter, the remaining water was mixed to prepare an external preparation composition.
Using the obtained external preparation composition, evaluation was performed by the method described above. The main ingredients used are shown in Table 1, and the compositions and evaluation results of the external preparation compositions are shown in Tables 2 to 11. In addition, the compounding amount described in each table is the active ingredient amount (mass %) of each component.

From Tables 2 to 11, it can be seen that the external preparation composition of this example has good film durability and moisture resistance, and also has a high effect of suppressing crystallization of component (A) and suppressing stickiness of the film. Recognize.
On the other hand, Comparative Example 1 which does not contain component (B), Comparative Examples 2 to 6 where component (B) does not contain two or more selected from the group consisting of components (B1) to (B3), and component (C) Comparative Example 7, which did not contain component (D), and Comparative Example 8, which did not contain component (D), were inferior to the effects of the present invention in any of the items.

In addition, Examples 1, 2, 4, 7, 12 and 15 using a combination of (B1) cellulose polymer and (B2) acrylic polymer; The thicknesses of the films formed in Example 19 using the combination and Example 27 using the combination of (B2) acrylic polymer and (B3) vinyl polymer were measured for thickness using the following method. The coating thicknesses in Examples 1, 2, 4, 7, 9, 12, 13, 15, 19, and 27 were 0.028 mm, 0.019 mm, 0.008 mm, 0.028 mm, 0.051 mm, and 0.02 mm, respectively. They were .029mm, 0.070mm, 0.098mm, 0.031mm and 0.020mm.

(Coating thickness)
20 μL/cm ² of the external preparation composition was applied to a vinyl tape ("Deleaded Type J3447" manufactured by Nitoms Co., Ltd.) and dried for 10 minutes on a hot plate heated to 32°C. After drying, the resulting coating was peeled off with tweezers, and the thickness of the coating was measured using a Digimatic indicator ("ID-C112XBS" manufactured by Mitutoyo, minimum display: 0.001 mm).

Furthermore, for Examples 1 to 3 and Comparative Examples 5 to 6, the removability of the films formed using the external preparation compositions was evaluated by the following method. The results are shown in Table 12.
(Removability of film)
An expert panelist applied 50 μL of the external preparation composition to an area of 2 cm x 2 cm on the inner side of the forearm using a Microman (manufactured by Gilson), and allowed it to air dry for 10 minutes. Thereafter, the film was immersed in a water bath at about 40° C., and the film was rubbed with a finger 10 times, and the remaining state of the film was visually observed. Next, the foamed cleaning agent (Kao Soap White) was brought into contact with the coating, and the coating was rubbed 10 times with a finger, the foam was washed away in a water bath, and the remaining state of the coating was visually observed. The removability of the film was evaluated according to the following evaluation criteria depending on the stage of removal, taking into consideration the moisture resistance of the film. Passed with an A.
A: It cannot be removed with lukewarm water at 40°C, but can be removed with a detergent.
B: Removed with lukewarm water at 40°C.
C: Cannot be removed even with lukewarm water at 40°C or with cleaning agents.

Examples 103 to 106 (Preparation and evaluation of external preparation composition)
Component (B) and other components listed in the table were mixed with component (C), component (D), and an appropriate amount of water, and then component (A) was mixed. Thereafter, the remaining water was mixed to prepare an external preparation composition.
Using the obtained external preparation composition, evaluation was performed by the method described above. Furthermore, the thickness of the coating, the contact angle of the composition and its rate of change, and the applicability were evaluated by the following methods. The main ingredients used are shown in Table 1, and the composition and evaluation results of the external preparation composition are shown in Table 13. The amounts listed in the table are the active ingredient amounts (% by mass) of each component.

(Contact angle of composition and rate of change)
At a temperature of 25° C., 2 μL of the external preparation composition listed in Table 13 was dropped onto the artificial leather Supplare (manufactured by Ideatex Japan) using an automatic contact angle meter (“DM-501i” manufactured by Kyowa Chemical Industry Co., Ltd.). Then, the contact angle was measured 10 seconds and 60 seconds after the droplet landed. Further, the rate of change in the contact angle from 10 seconds to 60 seconds after droplet deposition was calculated using the following formula (1).
Rate of change in contact angle = 1 - (contact angle after 60 seconds of droplet deposition)/(contact angle after 10 seconds of droplet deposition)...(1)

(Applicability)
After marking an area of 2 cm x 2 cm on the inner side of the forearm of the expert panelists, 24 μL of the external preparation composition shown in Table 13 was applied using Microman (manufactured by Gilson). The spread of the composition 30 seconds after application was visually confirmed, and the applicability was evaluated according to the following criteria.
A: It can be applied within an area of 2cm x 2cm.
B: Bleeding also occurs around a 2 cm x 2 cm area.
C: Dripping from an area of 2 cm x 2 cm.

Table 13 shows that external preparation compositions that have a high contact angle on artificial leather after 10 seconds and 60 seconds of droplet deposition and a small rate of change in contact angle from 10 seconds to 60 seconds after droplet deposition have a high contact angle on artificial leather. It can be seen that the coating properties are better.

Prescription examples 1 to 26 (preparation of external preparation composition)
According to the formulations in Tables 14 and 15, component (B) and other components were mixed with component (C), component (D), and an appropriate amount of water, and then component (A) was mixed. Thereafter, the remaining water was mixed to prepare an external preparation composition.

Prescription examples 27 to 30 (preparation of aerosol formulation)
According to the recipe in Table 16, component (B) and other components were mixed with component (C), component (D), and an appropriate amount of water, and then component (A) was mixed. Thereafter, the remaining water was mixed to prepare an external preparation composition that would become an aerosol stock solution. After filling this into an aerosol container (manufactured by Toyo Seikan Co., Ltd.), enclose DME so that the aerosol stock solution and the propellant dimethyl ether (DME) have the mass ratio shown in the table, and form an aerosol preparation. was prepared.

According to the present invention, it is possible to provide an external preparation composition containing a medicinal ingredient and capable of forming a film having excellent durability and moisture resistance, and a method for using the same.

Claims (14)

The following ingredients (A) to (D):
An external preparation composition containing (A) a medicinal ingredient (B) a water-insoluble polymer (C) a nonvolatile base (D) a volatile solvent,
The component (B) contains two or more types selected from the group consisting of (B1) cellulose polymer, (B2) acrylic polymer, and (B3) vinyl polymer,
The external preparation composition has a viscosity at 25° C. of 1.0 mPa·s or more and 10,000 mPa·s or less. The external preparation composition according to claim 1, wherein the mass ratio [(C)/(B)] of the component (C) to the component (B) in the external preparation composition is 0.01 or more and 50 or less. . The component (B) includes the component (B1) and the component (B2), and the mass ratio [(B2)/(B1)] of the component (B2) to the component (B1) is 0.05 or more and 30 or less. The external preparation composition according to claim 1 or 2. The component (B) includes the component (B1) and the component (B3), and the mass ratio [(B3)/(B1)] of the component (B3) to the component (B1) is 0.1 or more and 20 or less. The external preparation composition according to claim 1 or 2. The component (B) includes the component (B2) and the component (B3), and the mass ratio [(B2)/(B3)] of the component (B2) to the component (B3) is 0.05 or more and 30 or less The external preparation composition according to claim 1 or 2. The external preparation according to any one of claims 1 to 5, wherein the external preparation composition further contains water, and the content of water in the external preparation composition is 1% by mass or more and 70% by mass or less. Composition. The ingredient (A) is an anti-inflammatory analgesic ingredient, a local irritation ingredient, a blood circulation promoting ingredient, an antihistamine ingredient, a herbal medicine ingredient, an antipruritic ingredient, a local anesthetic ingredient, a keratin softening ingredient, a bactericidal ingredient, an antibacterial/antifungal ingredient, an immunosuppressant, and an antifungal ingredient. The external preparation composition according to any one of claims 1 to 6, comprising one or more selected from the group consisting of a virus component, a hair growth/hair growth component, a sebum suppressing component, an antiperspirant component, and a whitening component. External use according to any one of claims 1 to 7, wherein the component (C) is one or more selected from the group consisting of polar oils, non-polar oils, polyols, alkanolamines, and nonionic surfactants. agent composition. The external preparation composition according to any one of claims 1 to 8, wherein the component (D) is an alcohol having 4 or less carbon atoms. The external preparation composition according to any one of claims 1 to 9, wherein the content of the component (A) in the external preparation composition is 0.001% by mass or more and 30% by mass or less. The external preparation composition according to any one of claims 1 to 10, wherein the content of the component (B) in the external preparation composition is 0.01% by mass or more and 30% by mass or less. The external preparation composition according to any one of claims 1 to 11, wherein the content of the component (C) in the external preparation composition is 0.001% by mass or more and 40% by mass or less. The external preparation composition according to any one of claims 1 to 12, wherein the content of the component (D) in the external preparation composition is 10% by mass or more and 95% by mass or less. A method for using the external preparation composition according to any one of claims 1 to 13, comprising the following steps (I) and (II) in order.
Step (I): Applying the external preparation composition to the object and then drying it to form a film made of the external preparation composition.Step (II): Bringing the coating into contact with a cleaning agent, and then Step of washing with water to remove the film